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Inhaled therapy, medication administered by inhalation through the mouth, is the main method in the pharmacological treatment for patients with asthma and chronic obstructive pulmonary disease (COPD). The most effective inhaled therapy is an oil-based medication, and the purity and quality of this medication is critical for patients with these diseases. Inhaled therapies must be atomized into smaller droplets than those administered by the nasal route, so the medication can pass through the windpipe and into the lungs.
A pharmaceutical manufacturing company making an oil-based inhaled therapy was originally using a top-entry high-speed dispenser blade blender in a tank to emulsify oil and other dry powdered ingredients into a liquid stream. However, too often their in-tank mixer would not emulsify all of the oil properly. When it came time for a plant expansion, they sought other methods to achieve the quality level they required.
First, they tried a competitor brand’s shear blender with an impeller and screen to smooth out the product, but its shear rate was not high enough and the unit left the droplet size too big. Even after extended circulation it failed to completely emulsify the product.
Then they turned to Fristam. They learned of Fristam’s Powder Mixer at a trade show and how it combines the uniform powder induction of a Fristam FZX liquid-ring pump and the thorough blending of the Fristam FS shear blender. Wanting to quickly produce consistent product mixes, the pharma manufacturer contacted Fristam with their application. The challenge was to get the oil completely emulsified with the other dry powder medication to make an effective inhaler spray.
Based on their small batch sizes, less than 100 liters, Fristam’s Application Engineers recommended a Powder Mixer 10-52 with oil injector nozzle, located just before the entry into the shear blender, to inject the oil into the already mixed dry powder medication stream circulating in the batch process.
Their Fristam distributor arranged for a trial at their facility, with a Fristam rep and the distributor on-site. During the trial the Fristam Powder Mixer recirculated the product from the bottom of the small batch tank and back up to the top while the powders were slowly added to the water stream via the Powder Mixer’s funnel. This process ensured that the powders were fully dispersed before they ever got into the batch tank.
By slowly inducting the powders into the fluid stream, they were able to control the ratio of liquid to solid entering the shear blender. Once inside the shear blender the powders were subjected to intense turbulence and were fully dispersed on that first pass. After the dry powders had been added, the oil medication was injected into the product stream and emulsified.
The result was a completely mixed, shelf-stable product with the oil completely emulsified. As promised, Fristam’s Powder Mixer proved it could produce a quality oil and dry ingredients emulsion and solve the process with just this one piece of equipment, in place of what would typically take two or three.
In addition to improving their product quality, the Fristam Powder Mixer reduced their mixing time down from 3 hours to just 1 hour. The satisfied processor went on to order a Powder Mixer unit for the expansion and the company has since ordered more Powder Mixers for other locations.